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Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination

This study has been completed.
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited Identifier:
First received: February 23, 2011
Last updated: October 20, 2016
Last verified: October 2016
Phase I study of SPARC1023 alone and in combination with carboplatin

Condition Intervention Phase
Solid Tumor in Advanced Stage
Drug: SPARC1023 I
Drug: SPARC1023 II
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Sun Pharma Advanced Research Company Limited:

Primary Outcome Measures:
  • Determination of MTD [ Time Frame: One 21-day treatment cycle ]
    MTD for SPARC1023 in combination with carboplatin will be determined. MTD will be defined as the SPARC1023 dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects.

Secondary Outcome Measures:
  • Establishing the pharmacokinetic profile [ Time Frame: One 21-day treatment cycle ]
    Plasma levels of SPARC1023 and Carboplatin will be determined and PK parameters viz. Cmax, AUC0-t, AUC 0-∞, MRT, Tmax, t½ , Kel, Vd for SPARC1023 in combination with carboplatin will be evaluated.

Estimated Enrollment: 30
Study Start Date: October 2011
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPARC1023 I Drug: SPARC1023 I
IV administration
Experimental: SPARC1023 II Drug: SPARC1023 II
IV administration

Detailed Description:
Pharmacokinetic profile and dose escalation study of SPARC1023 when administered as 30-min infusion.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥18 years
  • ECOG Performance Status ≤ 1.
  • Estimated life expectancy of at least 12-weeks;
  • Measurable disease as per RECIST guideline (Version 1.1);

Exclusion Criteria:

  • Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in situ cervical cancer
  • Known hypersensitivity to the study drugs
  • Treatment with any anti-cancer agents within 28 days of study entry
  • Presence of clinically evident active CNS metastases, including leptomeningeal involvement, requiring steroid or radiation therapy
  Contacts and Locations
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Please refer to this study by its identifier: NCT01304303

United States, New York
SPARC Site 1
Buffalo, New York, United States
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
  More Information

Responsible Party: Sun Pharma Advanced Research Company Limited Identifier: NCT01304303     History of Changes
Other Study ID Numbers: CLR_10_23
Study First Received: February 23, 2011
Last Updated: October 20, 2016

Keywords provided by Sun Pharma Advanced Research Company Limited:
platinum processed this record on May 25, 2017